Submissions

In order to ensure the continued safe reporting of adverse events associated with our member's products and prevent consumer confusion, we strongly believe OTC and dietary supplement product incident reports should not be included in the CPSC safety incident database.

CHPA and its members support the Transparency Initiative and support FDA's goal of facilitating transparency that promotes public health and innovation, while maintaining confidentiality of trade secrets and individually identifiable patient information.

Today, the manufacturers of OTC medicines containing pseudoephedrine call on Congress to improve the Combat Methamphetamine Epidemic Act by requiring a unified, national electronic tracking system to block illegal sales of PSE‐containing medicines.

In this submission the task group provides updated data on the safety of counterirritants administered via patched or other novel dosage forms.

CHPA and its member companies have an interest and expertise in dosage delivery devices and support FDA's efforts to develop guidance for industry on this important topic.

CHPA appreciates the opportunity to nominate candidates to serve as the nonvoting industry representative for the FDA Center for Food Safety and Applied Nutrition (CFSAN) Food Advisory Committee.

Comments regarding a proposed rule on electronic submission requirements for postmarketing safety reports for human drug and biological products.

CHPA's Internal Analgesics task group seeks the agency's clarification of three provisions of the final rule.